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Sr./Principal Scientist, Formulation & Drug Product Development

Company: Medix---
Location: Rockville
Posted on: November 18, 2022

Job Description:


  • As the Senior/Principal Scientist, you will be a part of a team responsible for development of stable formulations, drug delivery systems, and manufacturing processes for recombinant adeno-associated virus (AAV) gene delivery products. In this role you will lead and design formulation development, characterization, and stability studies; design of drug product presentations; process development; clinical compatibility studies; and aseptic fills for GLP studies for multiple projects. You will work both independently and as a part of cross-functional teams on assigned projects, prioritize projects to meet departmental and organizational goals, and communicate results in technical reports and presentations.Responsibilities:
    • Lead program strategy and design individual formulation development, characterization, compatibility, and stability studies
    • Accountable for individual drug product process design, characterization studies, and aseptic fills for GLP studies
    • Review and author pertinent regulatory submission sections including INDs, BLAs, and equivalent
    • Identify and develop new technology platforms, equipment, methods and techniques in support of pharmaceutical development goals
    • Maintain familiarity with scientific literature and apply it appropriately to projects (such as evaluating new methodologies and techniques)
    • This role requires travel up to 10% of the timeQualifications:
      • Bachelor's degree in relevant scientific discipline with at least 13+ years direct relevant experience or Master's degree in relevant scientific discipline with 10+ years of relevant experience or PhD in relevant scientific discipline with 5+ years of industry or post-doctoral experience
      • Proven track record of applying theoretical and practical knowledge of formulation development and characterization principles
      • Experience with aseptic fill-finish of biologics, including unit operations, GMP requirements, media simulations, container/closure integrity, and regulatory requirements
      • Experience with bioanalytical techniques for product characterization and product stability evaluation, including dynamic light scattering, spectrophotometry, subvisible particle analysis, and HPLC
      • Experience authoring pertinent regulatory submission sections including INDs, BLAs, and equivalent
      • Substantial knowledge of relevant scientific literature and standard industry guidance documents
      • Ability to independently plan and perform experiments that support scientific activities and project goals
      • Ability to interpret data, draw conclusions, and recommend next steps
      • Ability to develop a wide range of methodologies/technologies and perform advanced data analysis
      • Ability to effectively communicate information and results in the appropriate format (i.e. lab notebooks, presentations, etc.)
      • Ability to lead internal and external cross-functional projects
      • Must be able to work collaboratively and effectively as part of a team
      • Prior industry experience preferred

Keywords: Medix---, Rockville , Sr./Principal Scientist, Formulation & Drug Product Development, Other , Rockville, Maryland

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